Influence of food on the bioavailability of a carbamazepine slow-release formulation.
The pharmacokinetics of a multiple-unit carbamazepine slow-release preparation were studied after a 12-hour fast and after a standardized breakfast in 24 healthy male volunteers. There was a small increase in mean values of AUC0-infinity and Cmax when the drug was given with food. The rate of absorption of slow-release carbamazepine, as reflected by HVD, appeared to be unchanged in the presence of food. Bioequivalence was concluded for the AUC0-infinity and HVD ratios applying the inclusion rule, thus demonstrating the lack of food interaction. The results indicate that administration of the investigated carbamazepine slow-release formulation to patients in the fasting or nonfasting state seems not to be a major consideration when deciding on the regimen.
Retzow
A
A
Desitin Arzneimittel GmbH, Medical Research, Hamburg, Germany.
Schürer
M
M
Schulz
H U
HU
D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002220:Carbamazepine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005215:Fasting; D018565:Food-Drug Interactions; D006801:Humans; D007408:Intestinal Absorption; D008297:Male
D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D002220:Carbamazepine